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Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02759211
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital

Brief Summary:
There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Backwards Walking Other: Forwards Walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Study Start Date : April 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Forwards Walking Group (FWG)
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Other: Forwards Walking
The Forwards Walking Group will perform forwards walking for the entire treatment intervention.

Experimental: Backwards Walking Group (BWG)
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Other: Backwards Walking
The Backwards Walking Group will perform backwards walking for the entire treatment intervention.




Primary Outcome Measures :
  1. Spatiotemporal Walking Parameters from Gaitrite Mat [ Time Frame: Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention ]
    Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention

  2. Gait Speed (Timed 25 Foot Walk) [ Time Frame: Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention ]
    Timed 25 Foot Walk

  3. Single Leg Stance (SLS) [ Time Frame: Change in Baseline SLS after 8 week intervention ]

Secondary Outcome Measures :
  1. Timed-up and Go [ Time Frame: Change in Baseline TUG after 8 week intervention ]
  2. Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: Change in Baseline ABC after 8 week intervention ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed clinical diagnosis of MS
  • Cognitively able to understand directions and complete protocol (score of 22 or greater on MMSE)
  • Signed Consent form approved by the Saint Francis Institutional Review Board
  • 18-65 years of age
  • PDDS score of 3 to 5 during the past 12 months
  • Completion of the 6 minute walk test
  • Speaks English (in order to safely complete intervention)

Exclusion Criteria:

  • Unwilling or unable to complete assessments and intervention
  • Current participation in physical therapy
  • Major changes in exercise habits in the past three months
  • Has had a relapse, acute Solumedrol treatment, or Acthar treatment in the past two months
  • Requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting
  • Current self-reported medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of DVT, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes [11]
  • Participants that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759211


Locations
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United States, Connecticut
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital Recruiting
Hartford, Connecticut, United States, 06112
Contact: Jennifer Ruiz, DPT    860-714-2149      
Sponsors and Collaborators
Mount Sinai Rehabilitation Hospital
National Multiple Sclerosis Society

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Responsible Party: Jennifer Ruiz, DPT, Research Manager, Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02759211     History of Changes
Other Study ID Numbers: SFH-16-27
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases